Sr RA Specialist

Irvine, California - Direct Hire - Job ID #496


Responsible for Regulatory and Compliance activities including tasks to ensure compliance with local, state, federal, any outside US requirements, and during new product development activities.


Supports activities to ensure products consistently meet or exceed established compliance and quality standards. Ensure that processes and work practices are compliant to applicable regulations and customer requirements pertaining to medical device and medical device manufacturing, and where appropriate, environmental requirements. Determine facility and product development RA strategies. Responsibilities include support for QA/RA related operational activities within the Quality Management System that may include processes such as recall investigations/activities, Audits, and Product Development/Design Control deliverables.






•   License renewals, updates and registrations including device listings, 510(k), GUDID, MAUDE, EUDAMED, OC Health, DTSC, etc

•   Support product and facility licenses, listings, technical file submissions.

Support/fulfill requirements related to CAFDB, USFDA, EU MDD, Health Can, OSHA, DTSC, OC Health, and other regulating agencies.

•   Collect and coordinate information and prepare regulatory documentation to regulatory agencies and customer partners.

•   Filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.

•   Prepare, support, and maintain deliverables for 510K and CE Marking (Technical

Files) submission documents and maintain records.

•   Review/approve changes for new and revised labels, labeling, marketing and website.

•   Review changes to existing products and SOPs to ensure compliance is maintained.

•   Assess regulatory issues and new requirements, determine their application within the QMS, product markets, or products and dissemination to

management/functional teams.

•   Assist in developing procedures to ensure regulatory compliance.

Support Product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables.

•   Prepare reports and documents necessary regulatory deliverables within Design

Controls and, where contractual, in support of customer QA/RA needs.

•   Advise on regulatory strategy

•   Support internal, agency and customer audits.



•   Support safety inspection findings.

•   Maintain and support material controls and deliverables to ensure requirements of RoHS, REACH, Conflict Minerals and Prop 65 are fulfilled.

•   Maintain current procedures.

•   Prepare a variety of written correspondence and documents.

•   Perform other duties as assigned.



4 or more years’ experience in creating and filing regulatory submissions. Must be competent with requirements of 21 CFR Quality System Regulations/cGMPs, ISO 13485

Quality System Standard and EU Medical Device regulations. Ability to research, write and support regulatory strategies and supporting documentation/reports. Knowledgeable

and proficient in creating/reviewing clinical and biological studies relating to establishing/satisfying regulatory requirements, product equivalency and safety. Ability to

analyze trends and draw logical conclusions. Must be proficient in scientific technical

writing. Ability to work with mathematical concepts such as probability and statistical inference to apply concepts to practical situations.


Critical thinking, facilitation, negotiation skills and collaboration abilities essential. Must be proficient in Microsoft Word/word processing and Excel/spreadsheet as essential skills.  Proficiency in Access and ERP systems a plus.




•   Provide deliverables for Regulatory and Safety compliance including reports. Must provide accurate and complete deliverables on time.

•   Self starter and can research internal, customer and regulatory requirements without prompt to ensure deliverables are on time, accurate and meets requirements.

•   Ascertain integrity of procedures.

•   Ensure that work is being performed in accordance with documented procedures.

•   Seek to improve and make changes in procedures to document “best practices”.

•   Keep up with all regulations and stay informed of organizational changes.

•   Remain well prepared for audits by external agencies/organizations (including, but not limited to Customers, FDA, ISO/Notified Body, OC Health, UL, EPA, OSHA).

•   Sustain a safe work environment.



Bachelor of Science. Four or more years established within Regulatory Affairs in Medical

Device industry. Medical device manufacturing/operational background a plus. Must have experience working with ISO Quality System Standard and Quality System Regulations. Experience in industrial hygiene/safety, government regulations, operational auditing, work flow analysis, technical writing, and manufacturing operations preferred.



Position requires regular contact both inside and outside the company at all organizational levels in order to carry out company business, policies, procedures, and

regulations.  Involves considerable tact, discretion, and persuasion in order to obtain

willing action and consent.  Regular contacts include, but are not limited to, the company



President, QARA, Production Management and Engineering.  Contact with employees, customers, vendors and regulatory agencies/registrars is frequent.



Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive amount of technical instructions in mathematical or

diagram form and deal with several abstract and concrete variables.

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